SecOnd-line Chemotherapy with RAmucirumab +/- pacliTaxel in Elderly advanced gastric or gastroesophageal junction cancer patients

Phase 1

Conditions: Elederly patient with advanced gastric or gastroesophageal junction cancer, after first line chemotherapy
MedDRA version: 20.0Level: LLTClassification code 10042080Term: Stomach cancerSystem Organ Class: 100000004864
MedDRA version: 20.0Level: LLTClassification code 10042088Term: Stomach cancer stage IV with metastasesSystem Organ Class: 100000004864
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2017-001683-37-FR

Lead Sponsor: Fédération Francophone de Cancérologie Digestive

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 112

Inclusion Criteria

•Histologically confirmed, unresectable, locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, whatever HER2 status
•Aged = 70 years
•WHO < 2
•Estimated life expectancy > 3 months
•Measurable or non-measurable disease according to RECIST 1.1 criteria
•Documented progression during first-line fluoropyrimidine- and platinum- or irinotecan containing chemotherapy (with or without anthracycline), or during the 4 months following the last cycle of such chemotherapy administered for metastatic or locally advanced disease, or during the 6 months following the last dose of adjuvant therapy containing fluoropyrimidine and platinium (treatment by immunotherapy is allowed)
•Adequate hepatic, renal and hematologic function:
oANC = 1 500 / mm3, platelets = 100 000 / mm3, hemoglobin = 9 g/dL
oBlood creatinine = 1.5 x ULN and creatinine clearance (MDRD formula) = 40 mL/min
oTotal bilirubin = 1.5 x ULN, AST and ALT = 3 x ULN (= 5 x ULN if hepatic metastasis)
oINR = 1.5 or INR = 3 for patients taking AVK and PTT = 5 seconds above the ULN
oDipstick proteinuria = 1+ or 24 hour proteinuria < 1 g in total
•EORTC QLQ-C30 + QLQ-ELD14, completed and faxed to the Randomization, Management and Analysis Center of the FFCD
•IADL geriatric questionnaire, completed and faxed to Randomization Management and Analysis Center of FFCD
•Signed informed consent ?
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112

Exclusion Criteria

•Known cerebral metastasis
•Prior treatment by taxanes
•Prior treatment with an antiangiogenic
•Neuropathy of grade = 2 (NCI-CTCAE 4.0)
•Unresolved partial or total bowel obstruction, inflammatory bowel disease (such as Crohn's disease or ulcerative colitis) or extensive gastrointestinal (GI) resection combined with chronic diarrhea
•GI perforation and/or fistulae in the 6 months preceding randomization.
•GI bleeding within the last 3 months of grade = 3 (NCI-CTCAE 4.0)
•Chronic use of antiplatelet drugs (including aspirin, but a daily intake of = 325 mg/day is accepted), non-steroidal anti-inflammatory drugs (ibuprofen, naproxen), dipyridamole, clopidogrel or similar agents
•Any arterial thromboembolic event (such as myocardial infarction, unstable angina, cerebrovascular accident or transient ischemic attack) in the 6 months preceding randomization
•A life-threatening episode of pulmonary embolism in the 6 months preceding randomization
•Deep-vein thrombosis, pulmonary embolism (PE), or any other significant thromboembolism (venous port or catheter thrombosis or superficial venous thrombosis are not considered significant” during the 3 months prior to first dose of protocol therapy
•Uncompensated congestive heart failure or uncontrolled arrhythmia
•Uncontrolled hypertension (= 160/100 mm Hg for > 4 weeks) despite properly observed antihypertensive therapy
•Cirrhosis at a level of Chilg-Pugh B or C; or cirrhosis (any degree) with a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis. Clinically meaningful ascites is defined as ascites from cirrhosis requiring diuretics or paracentesis
•Serious or unhealed wound, peptic ulcer or fracture within 28 days of randomization
•Radiotherapy or major surgery within 28 days of prior to first dose of protocol therapy, or minor surgery/subcutaneous venous access device placement within 7 days prior the first dose of protocol therapy
•Known allergy to paclitaxel or ramucirumab
•Another concomitant cancer or a history of cancer in the last 5 years, except cervical carcinoma in situ, cutaneous basal-cell or squamous-cell carcinoma, or any other carcinoma in situ deemed to be successfully treated
•Persons deprived of liberty or under supervision
•Impossibility of undergoing medical monitoring during the trial for geographic, social or psychological reasons